SOLICITATION NOTICE
R -- Baseline and Post-Infusion Assays of Immunologic Responses to a Gene Therapy Agent for Advanced Parkinson's Disease
- Notice Date
- 11/20/2012
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- 2790716
- Point of Contact
- Susan Nsangou, Phone: 301 443 2104
- E-Mail Address
-
nsangous@mail.nih.gov
(nsangous@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent, not a request for a proposal. A solicitation document will not be issued and proposals will not be requested. The National Institute on Drug Abuse (NIDA), Station Support/Simplified Acquisitions (SS/SA) Branch, on behalf of the National Institute of Neurological Disorders and Stroke (NINDS) intends to solicit, negotiate and award a purchase order on a noncompetitive basis with Southern Research Institute, 2000 9th Avenue, Birmingham, Alabama 35205-2708. The NINDS has a requirement for baseline and post-infusion assays of immunologic responses to a gene therapy agent for safety and efficacy determinations. The NINDS has a current protocol which infuses a gene therapy agent into the brains of subjects with Parkinson's disease. The trial is FDA-approved under IND 14,669. The FDA and Institutional Review Board (IRB) require assays of serum and cerebrospinal fluid for Anti-AAV2 antibody titers, GDNF protein levels, and anti-GDNF antibody levels. These assays are performed at baseline and at intervals up to five years following the gene therapy infusion, for a total of 10 timepoints per subject. Specifically, Southern Research Institute will develop the assays and provide instructions for shipment, run the screening serum anti-AAVA antibody on a weekly basis, and run the baseline and follow-serum GDNF level, serum GDNF antibody, CSF anti-AAV2 antibody, CSF GDNF level and CSF GDNF antibody in batches of <30 or every six months, whichever comes first. Southern Research Institute is the only known source to provide specialized assays for gene therapy. In addition, Southern Research currently has experience in similar assays for non-human studies of gene therapy. The NINDS has a requirement for the development of the assays within 45 days or less. The patients have been recruited under the protocol. The period of performance is one base year and up to four one-year option period(s.) Therefore based on the aforementioned facts, only one responsible source and no other supplies or services will satisfy agency requirements FAR 6.302-1. The acquisition is being conducted under FAR 12. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely with the discretion of the Government. Comments to this announcement, referencing synopsis number NOI2790716 may be submitted to the NIDA, SS/SA Branch, 31 Center Drive, Room 1B59, Bethesda, MD 20892, Attention: Susan A. Nsangou, Contracting Officer.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/2790716/listing.html)
- Record
- SN02934704-W 20121122/121120234659-9c34e72ac97e78ae777ee07c70b897ad (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |